A: Product quality depends on multiple development aspects, such as the product itself, the selected clone, and the upstream and downstream process. Freedom® CHO-S® cells offer all the typical CHO cell line benefits with respect to low protease levels and preferred glycan pattern.

4.

Q: How successful is the Freedom® CHO-S® Kit in creating stable clones?

A: CHO-S clones producing a model IgG protein were assessed for stability by comparing volumetric productivity for over 60 generations. Four out of the five clones that were tested maintained expression levels over 60 generations. Expression levels were considered stable if the titer at the end of the stability assessment (at generation 60) was at least 70% of the titer observed at the beginning of the stability study.

5.

Q: Can CHO-S® cells be used for the production of commercial products?

A: Yes. Freedom® CHO-S® cells are intended (with the purchase of a commercial license) for the development of biologics. They have been produced in a cGMP animal origin-free environment, and have been scaled up in a commercial setting to produce products for clinical testing.

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Components

A: All major components to complete the cell line development workflow are included in the Freedom® CHO-S® Kit: cGMP banked CHO-S® cells, a vector for cloning one or two genes, transfection reagent, competent cells, serum-free cell culture media and reagents. A complete list of components, including additional materials required but not included, can be found in the Freedom™ CHO-S® Kit manual.

A: A certificate of analysis (COA) demonstrating suitability for research use is available to everyone who purchases Freedom® CHO-S® cells. A full documentation package, including the cell line's lineage, history and cGMP testing results, is offered in conjunction with a commercial use license.

A: FreeStyle® MAX Reagent is included in the Freedom® CHO-S® Kit as the preferred transfection method. CHO-S® cells are also compatible with the Neon™ Transfection System (optimization of instrument settings is required).

13.

Q: How many transfections are typically required to get high-expressing clones from the Freedom® CHO-S® Kit?

A: When using limiting dilution cloning, careful evaluation of monoclonality of a clone is required before assessing stability of expression in order to avoid heterogeneous clones that can drift into separate populations and appear unstable.

15.

Q: What are some considerations for successful scale-up of CHO-S® cells?

Developed in collaboration with ProBioGen AG

A: Life Technologies has an ongoing collaboration with ProBioGen AG to create robust, easy to use, cell line kits optimized for industrial use. ProBioGen specializes in cell line and process development and has extensive experience with vector construction.

A: Yes. Life Technologies’ process sciences staff can assist you with the development of a customized stable cell line development program, which allows for the rapid screening of high producing clones. To learn more, email pd.direct@lifetech.com.